Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer
Malignant Pleural Effusion, Malignant Ascites
About this trial
This is an interventional treatment trial for Malignant Pleural Effusion focused on measuring Malignant Pleural Effusion, Malignant Ascites, Tocilizumab, IL-6 receptor antagonist, peritoneal cavity, pleural cavity, intraperitoneal, intrapleural
Eligibility Criteria
Inclusion Criteria: Subjects age 18-89 years old with pleural effusion or peritoneal ascites due to metastatic cancer Scheduled to undergo standard-of-care placement of pleural or peritoneal drainage catheter ECOG performance status: 0-2 Able to read and sign consent form in English and provide informed consent Exclusion Criteria: Laboratory abnormalities that indicate clinically significant inflammatory process AST/SGOT > 1.5 times the upper limit of normal ALT/SGPT > 1.5 times the upper limit of normal Total bilirubin > 1.5 times the upper limit of normal Creatinine > 1.5 times the upper limit of normal Hemoglobin < 9 gm/dL White blood cell count < 3,000/ mm3 Platelet count < 70,000/mm3 Absolute neutrophil cell count < 2,000 per mm3 Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits Pregnant women Active immunotherapy within 30 days; concurrent chemotherapy or targeted therapy is permitted but for patients with a history of prior immunotherapy, the most recent dose should be >30 days prior to the first treatment visit Investigational drug use within 30 days prior to first treatment dose History of systemic autoimmune disease Patient with known hypersensitivity to tocilizumab Active infection Medical contraindication or history of adverse reaction to acetaminophen or diphenhydramine -
Sites / Locations
- Allegheny Health Network Cancer Institute
Arms of the Study
Arm 1
Experimental
Treatment Arm - intracavitary tocilizumab
Four incremental weekly intra-cavitary doses of tocilizumab starting at 0.5μg/mL and increasing to 1.6μg/mL, 5μg/mL and 50μg/mL once a week over four weeks.